Kornimate/medical-research-clean huggingface dataset:
a study of a 35 mg delayed release formulation of risedronate for osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

the comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Eligibility criteria:
inclusion criteria: * female: 50 years of age or older * \>5 years since last menses natural or surgical * have lumbar spine or total hip bmd more that 2.5 sd below the young adult mean, or have lumbar spine or total hip bmd more than 2.0 sd below the young adult female mean value and also have at least one prevalent vertebral body fracture exclusion criteria: * history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia * bmi \>32 kg/m * use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone * hypocalcemia or hypercalcemia of any cause * markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
muscle mri in becker muscular dystrophy and in limb-girdle muscular dystrophy type 2i

Conditions: Becker Muscular Dystrophy; Limb-Girdle Muscular Dystrophy Type 2I

Summary: the purpose of this study is to investigate the paradoxical muscle enlargement in the calves and tongue seen in patients affected by becker muscular dystrophy and limb-girdle muscular dystrophy type 2i. the enlarged calves' muscle quality will be assessed primarily on the basis of the muscle structure on mri and based on a calculation of muscle strength per cross-sectional area.the findings will be compared with results from non-affected controls. additionally we want to describe the tongue muscle appearance on t1-weighted mri.

the purpose of this study is to investigate the paradoxical muscle enlargement seen in patients affected by becker muscular dystrophy and limb-girdle muscular dystrophy type 2i. becker and limb-girdle muscular dystrophies are both hereditary muscular disorders. both diseases appear clinically with shrinkage and muscle weakness of the muscles around the shoulder girdle and pelvis, while muscle hypertrophy of the calves and tongue is seen. the quality of the enlarged calves has to the investigators knowledge not previously been described, and their hypothesis is that the normal correlation between muscle strength and muscle cross-section is absent in the calf muscles. thus the investigators hypothesis suggests that there is no actual hypertrophy of the calf muscles, but rather a pseudohypertrofy with reduced force per cross-sectional area. with a picture of increased fat infiltration and disorganized muscle fibers. the enlarged calves' muscle quality will be assessed primarily on the basis of the muscle structure on mri (assessed on both t1 imaging, 3-point dixon scans, and diffusion tension imaging), and based on a calculation of muscle strength per cross-sectional area. isokinetic muscle dynamometry (biodex-4) will be used to measure muscle strength. the findings will be compared with results from non-affected controls. additionally the investigators want to describe the tongue muscle appearance on t1-weighted mri.

Eligibility criteria:
inclusion criteria: * danish patients genetically verified with either becker muscular dystrophy or limb-girdle muscular dystrophy type 2i * calves enlargement exclusion criteria: * patients who have metal implants in the body, for instance surgical clips, cochlear implants, pacemaker etc. * pregnant or breast-feeding patients * patients who are claustrophobic * atrophic calves

Keywords: bmd lgmd2i calf enlargement muscular dystrophy mri
tidal model's effect on coping and self-esteem

Conditions: Alcoholism

Summary: the aim of the study was to determine the effect of the psychiatric nursing approach based on the tidal model on coping and self-esteem in people with alcohol dependency.


Eligibility criteria:
inclusion criteria: * people with alcohol dependency were included in the study who were between 30 and 50 years of age who were admitted for treatment to the alcohol and substance addiction treatment clinic. exclusion criteria: * people with alcohol dependency who were severely depressed with a beck depression score of 41 or more and those with severe anxiety(a beck anxiety score of 26 or more) were not included in the study.

Keywords: alcoholics [m01.066]
rvu120 rollover study

Conditions: Advanced Solid Tumors; Acute Myeloid Leukaemia (AML); High-risk Myelodysplastic Syndrome

Summary: this is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a rvu120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study. to be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.

participants may continue treatment until loss of clinical benefit as judged by the investigator, unacceptable toxicity, start of subsequent anticancer therapy, or until any other criterion for withdrawal from the treatment or the study is met.

Eligibility criteria:
inclusion criteria: 1. the participant is enrolled in a rvu120 clinical study and receiving rvu120-based treatment given alone or in combination for at least 5 cycles. 2. the participant is currently benefiting from, and expected to continue to benefit from, rvu120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor. 3. the participant does not have access to commercially available comparator anticancer therapy. 4. contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5. the participant signed the rollover study icf prior to any study-related procedure or study data collection. 6. the participant agrees not to donate blood during study participation and until 28 weeks (\~6.5 months) after the last dose. 7. the investigator considers the participant to be eligible for participation in the rollover study. exclusion criteria: 1. presence of toxicity that cannot be adequately managed. 2. concurrent participation in any therapeutic clinical study other than the parent study.

Keywords: relapse refractory metastatic advanced solid tumor aml myelodysplastic syndrome
molecular and structural comparison of hypospadic and normal children prepuces

Conditions: Hypospadias

Summary: the aim of this study is to compare prepuce tissue samples from healthy male children who applied for circumcision and children with isolated hypospadias. estrogen receptor 1 (er1), androgen receptor (ar), fgfr2, transforming growth factor beta (tgf beta) and hoxa13 gene expression in the prepuce is planned to investigate via polymerase chain reaction (pcr) method. mucosal vascular and nerve densities, and extracellular matrix density of laminin and collagen protein is planned to investigate via immunohistochemical examination.


Eligibility criteria:
inclusion criteria: * to apply for circumcision, not to have any genitourinary abnormalities/conditions for control group. * to have isolated hypospadias for study group. exclusion criteria: * to have genitourinary surgery before.

Keywords: hypospadias prepuce hoxa13 fgfr2 tgf beta
lcz696 in advanced lv hypertrophy and hfpef

Conditions: Heart Failure; Essential Hypertension

Summary: patients with advanced lvh and hfpef will be randomly assigned in open-label fashion to receive lcz696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily, and will be treated for 24 weeks.

heart failure with preserved ejection fraction (hfpef) has a signiﬁcant morbidity and mortality, and therapies that have proven effective in hf with reduced ef have not been shown to improve long-term prognosis in hfpef. inhibition of circulating neprilysin could augment deficient np-receptor gc signaling and therefore be beneficial in hfpef, as suggested by the decrease in np following administration of valsartan/sacubitril in the phase 2 (paramount study). use of valsartan/sacubitril is currently being tested in the multicenter paragon-hf trial with hfpef patients. the investigators suppose the best candidates for lcz696 therapy will be patients with hfpef and advanced concentric lv hypertrophy and obesity, i.e. having the lowest bnp bioavailability.

Eligibility criteria:
inclusion criteria: 1. moderate/severe hypertensive left ventricular (lv) hypertrophy (lvmi ≥109 g/m² in women and ≥132 g/m² in men); 2. new york heart association (nyha) class ii-iii heart failure; 3. left ventricular ejection fraction \> 50%; 4. increased lv filling pressures assessed at rest or at peak exercise by echocardiography 5. body mass index (bmi) \> 30 kg/m² 6. signed and data informed consent exclusion criteria: 1. age ≤ 18 years; 2. evidence of myocardial ischemia during stress echocardiography; 3. chronic atrial flutter or atrial fibrillation; 4. alternative cause of left ventricular hypertrophy and impaired diastolic function (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis and etc.); 5. nyha classification i or decompensated heart failure at screening; 6. systolic blood pressure \ 180 mmhg; 7. diastolic blood pressure \ 100 mmhg; 8. anemia (hb \< 100 g/l); 9. significant left sided structural valve disease; 10. secondary hypertension; 11. dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases; 12. myocardial infarction or myocardial revascularization within the last 3 months of screening; 13. stroke or tia within the last 3 months of screening; 14. autoimmunic and oncological diseases; 15. impaired renal function, defined as egfr \< 30 ml/min/1.73 m²; 16. impaired liver function; 17. potassium concentration \>5.2 mmol/l.

Keywords: left ventricular hypertrophy diastolic dysfunction lcz696 hfpef hf lv filling pressures
comparison of effects of intravenous midazolam and ketamine on emergence agitation

Conditions: Psychomotor Agitation

Summary: compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. a high level of preoperative anxiety is a risk factor for emergence agitation using aono's four-point scale. midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. we aimed to compare the emergence agitation between midazolam group and ketamine group.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (\<2hr) exclusion criteria: * children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

Keywords: child, ketamine, midazolam
a treatment for depression via a gamified mobile phone application based on a new cognitive model

Conditions: Depression; Depressive Disorder; Clinical Depression; Major Depressive Disorder

Summary: the study is a randomized controlled treatment study comparing changes in depressive symptoms over 8 weeks between individuals with major depressive disorder (mdd) who have access to an ftp-based mobile phone application and a control group not engaging with the app. ftp, the process of facilitating thought progression, trains the brain's cognitive thought process to expand, accelerate, and be more creative, to alleviate depressive symptoms.

this project aims to determine the effectiveness of an ftp-based mobile phone application in the alleviation of clinical symptoms of depression. in an attempt to change thought progression to be broader and more readily expansive, we had translated paradigms meant to expand thinking patterns into engaging mobile games. our hypothesis is that the ftp-based mobile phone application will be able to decrease depressive clinical symptoms in a significant manner. participants meeting the inclusion criteria will be asked to play the app and undergo clinical and self-assessment evaluations regularly over the course of 8 weeks.

Eligibility criteria:
inclusion criteria: * consenting adults, ages 20-50 * able to read, understand and provide written informed consent in english * participants who are the sole users of an iphone or an android smartphone, and agree to download and use the digital mobile phone application as required by the protocol * participants who are comfortable using applications and games on their smartphones * participants with a current primary diagnosis of mdd or mild depression. madrs≥15 and \<35 * participants who are taking any medications which are fda approved or used off-label for mood or anxiety should be on a stable dosage for the past 6 weeks and have no plan to change dosage during the 8 weeks they will be in the study * participants who are receiving therapy should have been with the same therapist for the previous 60 days and have no plan to change therapy protocol during the 8 weeks of the study exclusion criteria: * participants who have plans to change their medications which are fda approved or used off-label for mood or anxiety or their therapy protocol during the 8 weeks of the study * participants who have made any changes to their therapy protocol, including starting therapy, stopping therapy, or changing providers within the past 60 days * participants who have made any changes to medications which are fda-approved or used off-label for mood or anxiety in the last 6 weeks * participants who have used a computer, web, or smartphone software-based application for mental health or depression in the last 6 weeks * being at imminent risk for suicidal behavior (via mini) note: other protocol-defined exclusion criteria applied.

Keywords: depression ruminations mobile-app therapeutic game ftp digital health mood disorders
assessment of the transfer of using levonorgestrel intrauterine system (lng ius) as a contraceptive to using it as part of hormone replacement therapy (hrt).

Conditions: Menopause

Summary: the study has been designed to look at the transfer from using lng ius for contraception only, in reproductive age to using it for endometrial protection in menopausal age. the main area of interest in the study is the pattern of any vaginal bleeding that occurs.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer healthcare ag, germany. bayer healthcare ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms. exclusion criteria: * pregnancy or lactation. * previous pelvic infections. * abnormal bleeding. * abnormal uterine cavity. * uterine polyps. * genital cancer. * liver diseases. * alcoholism or drug abuse.
helping our premature infants on to better motor skills (hop-on)

Conditions: Motor Development of Premature Infants

Summary: infants born very premature have biological risk factors for later developmental coordination disorder. parental stereotyping of infants as fragile and other environmental factors, such as spending long periods laying on their backs, also contribute to motor delay. this study aims to develop and evaluate a computer-based intervention (helping our premature infants on to better motor skills - hop-on) for parents of preterm infants. hop-on will model evidence based strategies to develop infants' fine and gross motor skills, and aims to reduce parental stereotyping. it is hypothesised that infants whose parents receive the hopon cd-rom/dvd and booklet will have better motor skills at 12 months adjusted age compared to those whose parents receive a control cd-rom/dvd and booklet. parents of infants born at less than 32 weeks gestation (target n = 138) will be recruited prior to discharge from the neonatal unit and randomised to either hop-on or control. the primary outcome is motor score (bayleys iii) at 12 months adjusted age. other outcomes are parental confidence and perceptions of infant capability at 3 months and quality of movement, infant growth, fine and gross motor movement and parenting stress at 12 months. data will be analysed blind to study condition and on an intention to treat basis.


Eligibility criteria:
inclusion criteria: * preterm infants born less than 32 weeks of gestation, and progressing well enough to have either been recently discharged from hospital, or being discharged from hospital within the next two weeks. * parent/s aged between 16-60 years of age, who have a preterm infant - born less than 32 weeks of gestation. both parent and infant inclusion criteria must be met for inclusion in the study. exclusion criteria: * parent/s of infants who are still receiving hospital care at 3 months adjusted age, and their premature infants who are still receiving hospital care at 3 months adjusted age. * parent/s of multiple births, where the number of infants is greater than two (three of more infants). * to avoid excessive travel costs, infants born outside the defined catchment area will be excluded from the study. there are no other exclusion criteria.

Keywords: premature infants motor development
safety study of radiofrequency ablation of locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Cancer

Summary: the purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. complications after the operation will be registered. moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

pancreatic cancer is the fourth leading cause of cancer related death in the western world. at time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. the median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. currently, there is no effective treatment for these patients. therefore, there is an urgent need for new therapies. radiofrequency ablation (rfa) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. rfa produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. the purpose of this study is to determine the safety of rfa-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of rfa 2. patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the umc utrecht 3. fully informed written consent given exclusion criteria: 1. patients younger than 18 years 2. pregnancy 3. patients with distant metastases 4. portal vein thrombosis seen on ct preoperatively

Keywords: pancreatic cancer locally advanced irresectable radiofrequency rfa
precision gold post market study in europe of pulmonary vein ablation catheter (pvac gold)

Conditions: Atrial Fibrillation

Summary: precision gold is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in europe. the purpose of the study is to evaluate asymptomatic cerebral embolic (ace) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the pulmonary vein ablation catheter (pvac) gold.

10-12 centers in europe will enroll up to 56 subjects who meet the inclusion/exclusion criteria and provide consent to participate in the study. subjects will undergo an ablation for paroxysmal af with the medtronic pvac gold (ce-mark). to assess for ace lesions, pre- and post-ablation procedure cerebral mris will be done along with a neurological exam (mini mental state exam). subjects will be followed for 1 month post-procedure when a repeat mri and neurological exam will be conducted if the subject had a positive mri at pre-hospital discharge.

Eligibility criteria:
inclusion criteria: * symptomatic af (\>/=2 recurrent af episodes that self terminate or af \</=48 hours that are cardioverted) * documentation of \>/=1 paroxysmal af events within past year * af symptoms (e.g. palpitations, fatigue, exertional dyspnea, effort intolerance) * prescribed to vitamin k antagonist (e.g. warfarin/coumadin) * age 18-70 years old * clinically indicated for a pulmonary vein ablation * willing and able to give informed consent * willing, able and committed to participate in all study required activities for the duration of the study exclusion criteria: * diagnosis of persistent or permanent af * prior left atrial ablation * presence of intracardiac thrombus * contraindicated for vitamin k antagonist * prescribed to direct thrombin or factor inhibitors (e.g. dabigatran, rivaroxaban) * prescribed to any investigational drug that may confound the study results * cardiac valve prosthesis * significant congenital heart defect (corrected or not) * pulmonary vein stents * pre-existing pulmonary vein stenosis * cerebral ischemic event (e.g. stroke, tia) that occurred within 6 months of study consent date * if female - pregnancy * participation in any other cardiovascular clinical study * contraindicated for mri * active sepsis * blood clotting abnormalities (genetic) * presence of left atrial myxoma * venous filtering device (e.g. greenfield filter) * invasive cardiac procedure in past 90 days